By Kurt R. Karst – A recent letter decision from FDA to the Patent and Trademark Office (“PTO”) concerning the availability of a Patent Term Extension (“PTE”) for U.S. Patent No. RE 41,571 (“the ‘571 patent), a method-of-use patent listed in the Orange Book covering Purdue …
By Kurt R. Karst – The first iteration of the Generic Drug User Fee Amendments (“GDUFA”) – “GDUFA I” – is now well into Year 4 of the 5-year program, and anticipation is growing as to what the second iteration of the program – “GDUFA II” …
By Kurt R. Karst – Speculating about the prospects that FDA will grant a period of marketing exclusivity – 5-year New Chemical Entity (“NCE”) exclusivity, 3-year new clinical investigation exclusivity, 7-year orphan drug exclusivity, or any other type of exclusivity or add-on exclusivity – upon the …
By Kurt R. Karst – On April 29, 2016, Represetatives Gerry Connolly (D-VA) and Morgan Griffith (R-VA) announced the introduction of H.R. 5127, the “Curb Opioid Misuse by Advancing Technology (COMBAT) Act.” The COMBAT Act is the latest effort by Congress to incentivize the development of …
By Kurt R. Karst – Disputes involving non-patent marketing exclusivity available to 505(b)(1) and 505(b)(2) NDA applicants – either 5-year New Chemical Entity (“NCE”) exclusivity, 3-year new clinical investigation exclusivity, or 7-year orphan drug exclusivity – have increased dramatically over the past few years, and there’s …
By Kurt R. Karst – Last month, the Federal Trade Commission (“FTC”) announced the filing of a Complaint For Injunctive and Other Equitable Relief in the U.S. District Court for the Eastern District of Pennsylvania alleging that Endo Pharmaceuticals Inc. (“Endo”) and other drug manufacturers, including …
For generic drug companies, the biggest and most expensive challenge to a US product launch is the patent that covers the Active Pharmaceutical Ingredient (“API”). Notoriously, only one such patent has ever been invalidated for obviousness. On Thursday, April 14, 2016, from 9:00 AM – 10:00 …
By Kurt R. Karst – Ever since FDA Commissioner Dr. Robert M. Califf's February 2016 call for a sweeping review of FDA policies concerning opioids (in response to growing pressure from Congress), the Agency has been on a tear to meet that call with new policies and requirements. There's the recent announcement …
By Kurt R. Karst – Earlier this week, the U.S. District Court for the District of Columbia (Judge Rudolph Contreras) issued a 33-page Memorandum Opinion in a case stemming from a Complaint filed in June 2015 by Ferring Pharmaceuticals Inc. (“Ferring”) against FDA challenging the Agency’s …
By Kurt R. Karst – The ongoing controversy over drug pricing has raised debate on many aspects of drug approval, and, in particular, on the approval of generic drugs. Over the past several months, there have been numerous letters from Members of Congress to FDA – …
By Kurt R. Karst – Earlier this week at the Generic Pharmaceutical Association’s (“GPhA”) annual meeting in Orlando, Florida, Dr. Kathleen (“Cook”) Uhl, Director of the Office of Generic Drugs (“OGD”), gave the keynote address, providing the generic drug industry with a much-anticipated lowdown on FDA’s …
By Kurt R. Karst – Question: When was the first time FDA approved an ANDA containing a Paragraph IV certification to a patent listed in the Orange Book for DIPRIVAN (propofol) Injection, 10 mg/mL, approved under NDA 019627, and granted a period of 180-day exclusivity? Buehler, Buehler? If …
By Kurt R. Karst – We love precedents – particularly unusual precedents that are wrapped up in drug approval histories. A couple of years ago we learned about a new precedent concerning the “date of approval” of a drug product. That term is defined in an …
By Kurt R. Karst – The ink from President Obama’s signature on Public Law No. 114-89, the “Improving Regulatory Transparency for New Medical Therapies Act” (or “IRTNMTA”), was hardly dry when the company that led the charge to change the law, Eisai Inc. (“Eisai”), asked the …
By Kurt R. Karst – Those folks who have been following this blog for several years have a good sense about the depths of this blogger’s passion for the Orange Book. There’s the license plate (“ORNGBUK”), the trip to the summit of Mt. Kilimanjaro with the …
